Bliss Pharmaceutical denies FDA allegations
Bliss GVS Pharma limited (BLISS), at the weekend dismissed the classification of Food and Drugs Authority (FDA) that products of the company, which are distributed locally by Tobinco Pharmaceuticals Limited are fake.
“We will like to state emphatically that all our products have been subjected to stringent quality standards and meet the required accreditations in India. It is unfortunate that the FDA released a statement classifying our products as fake,” a statement issued by the company said.
The statement, which was copied to Ghana News Agency in Accra, said the claim by FDA led to the blacklisting of the company manufactured medicinal products for the Ghanaian market.
It said BLISS complies with all norms laid down by Food and Drug Administration for manufacture of its products and maintains high international GMP standards.
BLISS has been supplying high quality medicines to Ghana for the past 13 years, which meet the stringent quality standards as prescribed by the Food and Drug Administration.
The statement said the company has been extending a helping hand to the FDA Authority on all issues bothering on compliance of regulatory requirements.
“We have made payments for renewal of our product registrations and the renewal process is on.”
It said if the FDA had given BLISS the chance and time to comply with points they raised about the company’s products “we would have been in a position to explain to them better”.
The statement said BLISS is a publicly owned company, incorporated on 11 December, 1984.
It has more than 28 years of experience in manufacturing, marketing and exporting more than 250 formulations in various dosage forms to more than 50 countries across the globe.
The statement said all business processes of BLISS, including production, quality, supply chain, sales and distribution are integrated on a very robust “SAP ERP” platform.
“BLISS maintained high levels of compliance owing to strict implementation of GMP, GLP, ICH guidelines.
“We would also like to emphasise that until date our product has not been failed in quality aspects.”
The statement said BLISS is committed to ensure public health and safety “and has never and would not compromise on this”.
“Over the last decade, we have created an organisation which adheres to the highest standards of ethics while making quality medicines available to the society.
“We assure the Ghanaian public that we will take all necessary steps to assist the FDA in its quest to protect public safety and to continue to provide the quality assured and affordable medicines in Ghana,” the statement said.
Source: GNA